Vesicare

Vesicare Manufacturers

• Physicians Total Care, Inc.
  

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  Vesicare | Physicians Total Care, Inc.

  

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  2.1 Dosing Information

  The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

  VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food.

  2.2 Dose Adjustment in Patients with Renal Impairment

  For patients with severe renal impairment (CLcr <30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended [see Warnings and Precautions (5.6); Use in Specific Populations (8.6)].

  2.3 Dose Adjustment in Patients with Hepatic Impairment

  For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see Warnings and Precautions (5.5); Use in Specific Populations (8.7)].

  2.4 Dose Adjustment in Patients Taking CYP3A4 Inhibitors

  When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of VESIcare greater than 5 mg is not recommended [see Drug Interactions (7.1)].

  2.3 Dose Adjustment in Patients with Hepatic Impairment

  For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see Warnings and Precautions (5.5); Use in Specific Populations (8.7)].

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• Cardinal Health
  

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  Vesicare | Method Pharmaceuticals, Llc

  

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  The usual adult dose may be taken as one caplet daily, or as directed by a licensed medical practitioner.

  FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body, and supplies the active folate substrate, THF for use in transformylation and methylation biochemistry.1

  Folates are best known for reducing the incidence of fetal neural tube defects (NTDs).2,3,4 NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.4,5 During the first four weeks of pregnancy – when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. Folate is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry. Folate is involved in transformylation and methylation metabolism as well as, indirectly, succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate.4 Other ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate.4,5

  L-methylfolate supplementation increases the formation of endothelial nitric oxide synthase resulting in increase nitric oxide. This causes vasodilation to the nerves, increasing blood supply to the nerves, and reducing vascular oxidative stress.6 L-methylfolate supplementation also increases nitric oxide levels by increasing the amount of tetrahydrobiopterin (BH4). BH4 is required for nitric oxide synthesis.7

  FOLATE COENZYMES, COFACTORS, AND COMETABOLITES - The following ingredients are added to enhance the bioavailable potential of folate, and include:

  METHYLCOBALAMIN - Methylcobalamin is required for two important reactions: the conversion of methylmalonyl CoA to succinyl CoA, a Krebs cycle intermediate, and the conversion of homocysteine to methionine, a reaction in which the methyl group of L-methylfolate is donated to remethylate homocysteine. Homocysteine has been found to stimulate or alter transcription factors involved in inflammation, with an important ancillary consequence of BH4 depletion. For example, it has been reported that homocysteine-mediated activation of sterol regulatory element binding protein (SREBP) upregulates expression of 3-hydroxy-3-methyl-glutaryl-coenzyme (HMG-CoA reductase) with increased biosynthesis and cellular uptake of cholesterol, the depletion of BH4 being a secondary effect.

  FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 establish that increased folate is proper supplement in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy, and childhood.8,9 Folate metabolism may be affected by malabsorption issues that differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states “The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added].1 The actual amount and source of folate require the supervision of a licensed medical practitioner to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that “dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated.9”  When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. "Patients should be kept under supervision of a licensed practitioner and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added].9” In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote “... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added].10”

  Summary: This product is a dietary management / prescription folate that, due to advanced folate levels, requires administration under the care of a licensed medical practitioner. The "Rx" on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B12 deficiency (pernicious anemia). The "Rx" status and a National Drug Code (NDC), or similar Product Code, facilitate pedigree reporting requirements and supply-chain control as well as, in some cases, insurance-reimbursement applications.

  These statements have not been evaluate by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

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• Astellas Pharma Technologies, Inc.
  

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  Vesicare | Astellas Pharma Technologies, Inc.

  

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  2.1 Dosing Information

  The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

  VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food.

  2.2 Dose Adjustment in Patients with Renal Impairment

  For patients with severe renal impairment (CLcr <30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended [see Warnings and Precautions (5.7); Use in Specific Populations (8.6)].

  2.3 Dose Adjustment in Patients with Hepatic Impairment

  For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see Warnings and Precautions (5.6); Use in Specific Populations (8.7)].

  2.4 Dose Adjustment in Patients Taking CYP3A4 Inhibitors

  When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of VESIcare greater than 5 mg is not recommended [see Drug Interactions (7.1)].

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• Cardinal Health
  

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  Vesicare | Blenheim Pharmacal, Inc.

  

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  Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
  

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